Environmental Monitoring Associate

4 weeks ago

Exton PA, United States Joulé Full time

Job Title: Environmental Monitoring Associate Location: Exton, PA Type: Contract to hire Schedule: Monday - Friday 8am-5pm Overview: Cell and gene therapy company is looking for an experienced Quality Control- Environmental Monitoring Associate to join their team Responsibilities: Perform viable and non-viable environmental monitoring in support of Manufacturing and Quality Control in the form of air testing, surface testing, personnel testing and particulate monitoring Perform batch record verification of critical processing steps performed by Manufacturing during aseptic product manufacture, ensuring accuracy of steps performed Perform Growth Promotion testing on prepared media Direct Sterile Media Fill Trials and perform support testing Maintain housekeeping in the Quality Control laboratories Assist the Quality Control department in daily operations, as needed Author and revise QC SOPs as necessary to maintain compliance Timely response to Out Of Specification (OOS) results, including notification to area supervision Communicate with the individual Operations Departments (Manufacturing, Quality Assurance, Facilities) to ensure that Company objectives are met on schedule Employment of myriad analytical equipment in support of product quality Completion of thorough Manufacturing Investigation Reports (MIRs) to ensure that potential problems and root causes are identified, impact assessed and actions to prevent recurrence are considered and implemented Requirements: Minimum Bachelor of Science degree in a scientific discipline Knowledge of Current Good Manufacturing Practice and Industry standards Experience in a similar role in the biologics or pharmaceutical industry Experience in aseptic processing and mammalian cell culture production Familiarity of basic laboratory equipment such as microscopes, pH meters, incubators Excellent verbal, written and organizational skills Good interpersonal and communication skills Must be open to occasional off shift and weekend work #M3

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